Okay,

As far as the clinical utility, I was unclear as to what the issue there was, but based on the artical,

"The good news is that the agency may be comfortable with the “clinical utility” of
Afrezza because MannKind was adamant that this did not appear in the latest CRL."

It seems Mannkind will address this issue anyways in the latest phase III trials by treating type 1 and 2 diabetics? --that is my understanding.

As far as the bioequivalence problem, I understand that is a separate issue than the fact that there is a new inhaler, and that it uses 30% less medication which requires new trials.

From what I understand, by comparing the two inhalers with two groups of people, the bioequivlancy issue would be asserted. However, was that issue previously asserted with the mixed model method, or the fda demanded model as noted in the letter that was sent to the fda concerning the medtone?

Has the bioequivalence issue already been addressed by Mannkind, and accepted by the fda?